Sanitary fluid collection, application and storage device and methods of use of same

Abstract

The present disclosure includes but is not limited to a device for collecting samples, especially liquid samples to be tested for the presence of an analyte, especially for drugs of abuse, antibodies, antigens and biological moieties such as steroids and glucose. In particular, the disclosure describes improvements in collection device design that provide a simple, non-invasive, non-hazardous method of collecting samples from a subject or patient, especially liquid samples such as saliva, oral fluid and urine. The collected sample can be stored in the disclosed device and the device can be used to apply, in a drop-wise manner, an aliquot of the sample directly to a test device.

1 . A device, for collecting fluids, storing and applying the fluid to a test device, comprising: 
 a. a sample collector having an absorbent member, configured to collect a liquid sample;    b. a sample container, wherein a portion of said container is flexible;    c. an assembly fluidly configured to expel the expressed sample from the device; and    d. a cap.    
     
     
         2 . The device of  claim 1 , wherein said sample collector further comprises a support member and a flange, wherein said absorbent member is attached to said support member.  
     
     
         3 . The device of  claim 2 , wherein said absorbent member further comprises a foam.  
     
     
         4 . The device of  claim 2 , wherein said absorbent member further comprises a sponge.  
     
     
         5 . The device of  claim 2 , wherein said absorbent member is treated with a solution that stimulates salivation in a subject from which the sample is to be collected.  
     
     
         6 . The device of  claim 2 , wherein said support member is substantially rigid and optionally attaches to said assembly.  
     
     
         7 . The device of  claim 1 , said assembly being removably attached to the exterior surface of said first end of said barrel by a hinge member.  
     
     
         8 . The device of  claim 1 , said container further comprising a barrel having first and second ends and an exterior and an interior, said first end further comprising an orifice providing access to said interior of said barrel for receiving said absorbent member.  
     
     
         9 . The device of  claim 1 , said container having flexible sides such that the sides of said container can be manually pressed inward, whereby, when said device is in the inverted position, manually applied pressure on the container sides causes expression of a portion of the sample from said assembly.  
     
     
         10 . The device of  claim 1 , wherein said container is shaped like a squeeze bulb.  
     
     
         11 . The device of  claim 1 , wherein said container is cylindrically, lobularly, spherically, pear, tear-drop or box-like shaped.  
     
     
         12 . The device of  claim 1 , wherein said assembly is configured to expel liquid as a stream, drops, droplets, a mist, or the like.  
     
     
         13 . The device of  claim 1 , said assembly further comprising: a lid having a dropper tip, said dropper tip having a mouth.  
     
     
         14 . The device of  claim 13 , wherein said lid is adapted to tightly seal the first end of said barrel.  
     
     
         15 . The device of  claim 8 , the bottom of said assembly being shaped so as to be snapably attachable to said first end of said barrel and thereby close said container.  
     
     
         16 . The device of  claim 8 , said first end of said barrel having first threads.  
     
     
         17 . The device of  claim 16 , said assembly having second threads shaped to thread with said first threads of said barrel.  
     
     
         18 . The device of  claim 1 , wherein said container is adapted to allow for squeezing and when the device of  claim 1  is in an inverted position said squeezing of said container causes drops of the sample to be expelled from the device of  claim 1  through said orifice of said dropper tip.  
     
     
         19 . The test device of  claim 1 , wherein said sample is a biological sample.  
     
     
         20 . The test device of  claim 1 , wherein said sample is a liquid or a solution comprising a biological sample.  
     
     
         21 . The test device of  claim 1 , wherein said sample is selected from the group consisting of blood, plasma, saliva, oral fluid, cerebrospinal fluid, urine, fecal material, mucous, vaginal or oral swabs, semen, tissue, fluid or puss exudates, aspirates, cell culture, conditioned media from a cell culture, homogenized cell culture, homogenized tissue and solutions derived from solid or semi-solid biological samples.  
     
     
         22 . The test device of  claim 1 , wherein said analyte of interest is selected from the group consisting of drugs, drugs of abuse, alcohol, poisons, bacteria, viruses, proteins, sugars, carbohydrates, lectins, fats, antibodies, receptors, hormones, etiological agents and biological metabolites.  
     
     
         23 . A device for collecting and storing a fluid, and applying an aliquot of the fluid to a test device, comprising: a sample collector having a foam or sponge absorbent member, configured to collect a liquid sample; a container having flexible sides and that receives the sample collector; and assembly fluidly connected to the container and configured to expel a portion of the sample from the device.  
     
     
         24 . The device of  claim 23 , wherein said absorbent member is treated with a solution that stimulates salivation in a subject from which the sample is to be collected.  
     
     
         25 . The device of  claim 23 , said container further comprising a barrel having first and second ends and an exterior and an interior, said first end further comprising an orifice providing access to said interior of said barrel for receiving said sample.  
     
     
         26 . The device of  claim 23 , said container having flexible sides such that the sides of said container can be manually pressed inward, whereby, when said device is in the inverted position, manually applied pressure on the container causes expression of the sample from said assembly.  
     
     
         27 . The device of  claim 23 , wherein said container is shaped like a squeeze bulb.  
     
     
         28 . The device of  claim 23 , wherein said container is cylindrically, lobularly, spherically, pear, tear-drop or box-like shaped.  
     
     
         29 . The device of  claim 23 , wherein said assembly is configured to expel liquid as a stream, drops, droplets, a mist, or the like.  
     
     
         30 . The device of  claim 23 , said assembly being removably attached to the exterior surface of said first end of said barrel by a hinge member.  
     
     
         31 . The device of  claim 23 , said assembly further comprising: a lid having a dropper tip, said dropper tip having a mouth.  
     
     
         32 . The device of  claim 23 , the bottom of said assembly being shaped so as to be snapably attachable to said container and thereby close said container.  
     
     
         33 . The device of  claim 25 , said first end of said barrel having first threads.  
     
     
         34 . The device of  claim 25 , said assembly having second threads shaped to thread with said first threads of said barrel.  
     
     
         35 . The device of  claim 25 , wherein said assembly is adapted to tightly seal the first end of said barrel.  
     
     
         36 . The device of  claim 23  wherein said container is adapted to allow for squeezing and when the device of  claim 23  is in an inverted position said squeezing of said container causes drops of the sample to be expelled from the device of  claim 23  through said orifice of said dropper tip.  
     
     
         37 . The test device of  claim 23 , wherein said sample is a biological sample.  
     
     
         38 . The test device of  claim 23 , wherein said sample is a liquid or a solution comprising a biological sample.  
     
     
         39 . The test device of  claim 23 , wherein said sample is selected from the group consisting of blood, plasma, saliva, oral fluid, cerebrospinal fluid, urine, fecal material, mucous, vaginal or oral swabs, semen, tissue, fluid or puss exudates, aspirates, cell culture, conditioned media from a cell culture, homogenized cell culture, homogenized tissue and solutions derived from solid or semi-solid biological samples.  
     
     
         40 . The test device of  claim 23 , wherein said analyte of interest is selected from the group consisting of drugs, drugs of abuse, alcohol, poisons, bacteria, viruses, proteins, sugars, carbohydrates, lectins, fats, antibodies, receptors, hormones, etiological agents and biological metabolites.  
     
     
         41 . A method of collecting a fluid sample, using the device of  claim 1  or  23 , comprising: 
 a. providing the fluid sample;    b. contacting the fluid sample with said sample collector;    c. inserting said sample collector into said container; and    d. closing said container.    
     
     
         42 . A method of applying a collected fluid sample to a test device, using the device of  claim 1  or  23 , comprising: 
 a. inverting the device of  claim 1  or  claim 23;     b. squeezing said container; and    c. applying drops of the collected fluid sample to a test device.    
     
     
         43 . A method of collecting a fluid sample, using the device of claim or  claim 23 , comprising: 
 a. providing the fluid sample;    b. contacting the fluid sample with an absorbent sample collector;    c. inserting said absorbent sample collector into a sample container;    d. screwing a top assembly on to said sample container.    
     
     
         44 . A method of applying a collected fluid sample to a test device, using the device of  claim 1  or  claim 23 , comprising: 
 a. removing said cap of the device of  claim 1  to expose said dropper assembly;    b. inverting the device of  claim 1;     c. squeezing at least one side of said sample container; and    d. applying expressed drops of the collected fluid sample to a test device.    
     
     
         45 . A kit, comprising: at least one device of  claim 1  or  claim 23  packaged together with instructions for use of said device.  
     
     
         46 . The kit of  claim 45 , further comprising a test device.